Viral; Infection, Coxsackie(Virus)Phase 1PROVENTNCT04690426
PROtocol for Coxsackievirus VaccinE in Healthy VoluNTteers
A Phase 1 study testing PRV-101 in people with Viral; Infection, Coxsackie(Virus), run by Provention Bio, Inc. at 1 site in Finland.
Trial summary
Phase 1, first-in-human, randomized, double-blind, placebo-controlled, multiple-dose-escalation study to evaluate the safety, tolerability and immunogenicity of PRV-101, a coxsackie virus B vaccine, in healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Viral; Infection, Coxsackie(Virus)
- What is being tested?
- PRV-101
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteFinland
- Study dates
- 14 Dec 2020to 7 Dec 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adults, males and females, ages 18 to 45 yrs, with BMI 19 to 30 kg/m2
- Women of childbearing potential must have negative pregnancy test and agree to use an acceptable method of highly effective contraceptive
- Men must either have a vasectomy or agree to use highly effective contraception
Who cannot join
- Prior or current clinically significant medical illness or disorder
- Has celiac disease or type 1 diabetes or related autoantibodies
- Has active acute or chronic/latent infection, or history of recent serious infection
- Recent acute illness or recent major illness, hospitalization or surgery
- Recent history of alcohol or drug abuse
- Received an experimental antibody or biologic therapy in last 6 months
- Received live, inactivated or subunit virus vaccine or a bacterial vaccine within last 4 weeks
- Intolerance or hypersensitivity to vaccines or vaccine components or has a drug or food allergy or allergic disease requiring medication
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, First-in-Human, Randomized, Double-Blind, Placebo-Controlled, Multiple-Dose-Escalation Study to Evaluate the Safety, Tolerability, and Immunogenicity of PRV-101, a Coxsackie Virus B (CVB) Vaccine, in Healthy Adult Subjects
Phase 1, first-in-human, randomized, double-blind, placebo-controlled, multiple-dose-escalation study to evaluate the safety, tolerability and immunogenicity of PRV-101, a coxsackie virus B vaccine, in healthy volunteers.
Read the detailed description
Thirty two healthy adult subjects will be enrolled into 2 dose cohorts (low-dose and high-dose cohorts, 16 subjects per cohort) and will be randomized in a double-blind manner to PRV-101 or placebo in a 3:1 ratio. Each subject will receive up to 3 administrations of the study drug (PRV-101 or placebo) at 4-week intervals and will be followed for 24 weeks after the final dose. Each cohort will start with a sentinel dosing group (2 subjects). Cohort 2 will commence after safety data from the first 2 doses from all Cohort 1 participants are reviewed.
- Conditions
- Viral; Infection, Coxsackie(Virus)
- Being tested
- PRV-101, Placebo
- Keywords
- Coxsackie Virus B, vaccine
- Medical subject headings
- Coxsackievirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRV-101Biological
Coxsackie Virus B vaccine
PlaceboOther
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1, Low Dose, Placebo | Placebo comparator | Low dose of placebo by intramuscular injection, 3 doses at 4-week intervals Receives: Other: Placebo |
| Cohort 1, Low Dose, PRV-101 | Experimental | Low dose of PRV-101 by intramuscular injection, 3 doses at 4-week intervals Receives: Biological: PRV-101 |
| Cohort 2, High Dose, Placebo | Placebo comparator | High dose of placebo by intramuscular injection, 3 doses at 4-week intervals Receives: Other: Placebo |
| Cohort 2, High Dose, PRV-101 | Experimental | High dose of PRV-101 by intramuscular injection, 3 doses at 4-week intervals Receives: Biological: PRV-101 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of treatment-emergent adverse events (safety and tolerability)
Adverse events will be assessed by frequency and criteria for severity (mild, moderate or severe)
Measured: Throughout the 32 weeks of the study
Secondary outcomes (2)
Development of neutralizing antibodies to coxsackie B virus (immunogenicity, efficacy)
Proportion of responders (ie, those that seroconvert or have at least a 4-fold increase in neutralizing antibody titers to any of the coxsackie B virus strains as measured by plaque reduction assay using serial serum dilutions)
Measured: Days 1, 29, and 57 and Weeks 12 and 32
Titer of antibodies to coxsackie B virus (immunogenicity, efficacy)
Mean and peak geometric mean serum IgG titers of antibodies against any of the coxsackie B virus strains, measured by ELISA
Measured: Days 1, 29 and 57 and weeks 12 and 32
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2020
- Study start14 Dec 2020
- Primary completion7 Dec 2021
- Study completion7 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Viral; Infection, Coxsackie(Virus)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Provention Bio, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Chief Scientific Officer, Principal investigator, CRST Oy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04690426
- Sponsor's protocol ID
- PRV-101-001
- Acronym
- PROVENT
- Status last verified
- Jul 2022
- First submitted
- 15 Dec 2020
- Last updated
- 25 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hyoty H, Kaariainen S, Laiho JE, Comer GM, Tian W, Harkonen T, Lehtonen JP, Oikarinen S, Puustinen L, Snyder M, Leon F, Scheinin M, Knip M, Sanjuan M. Safety, tolerability and immunogenicity of PRV-101, a multivalent vaccine targeting coxsackie B viruses (CVBs) associated with type 1 diabetes: a double-blind randomised placebo-controlled Phase I trial. Diabetologia. 2024 May;67(5):811-821. doi: 10.1007/s00125-024-06092-w. Epub 2024 Feb 19.
PubMed 38369573
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, First-in-Human, Randomized, Double-Blind, Placebo-Controlled, Multiple-Dose-Escalation Study to Evaluate the Safety, Tolerability, and Immunogenicity of PRV-101, a Coxsackie Virus B (CVB) Vaccine, in Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT04690426
- Acronym / sponsor ID
- PROVENT / PRV-101-001
- Conditions
- Viral; Infection, Coxsackie(Virus)
- Keywords
- Coxsackie Virus B, vaccine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Provention Bio, Inc.Industry (pharma, biotech, devices)
- Study start
- 14 Dec 2020 (actual)
- Primary completion
- 7 Dec 2021 (actual)
- Study completion
- 7 Dec 2021 (actual)
- First posted
- 30 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Phase 1, first-in-human, randomized, double-blind, placebo-controlled, multiple-dose-escalation study to evaluate the safety, tolerability and immunogenicity of PRV-101, a coxsackie virus B vaccine, in healthy volunteers.
Detailed description
Thirty two healthy adult subjects will be enrolled into 2 dose cohorts (low-dose and high-dose cohorts, 16 subjects per cohort) and will be randomized in a double-blind manner to PRV-101 or placebo in a 3:1 ratio. Each subject will receive up to 3 administrations of the study drug (PRV-101 or placebo) at 4-week intervals and will be followed for 24 weeks after the final dose. Each cohort will start with a sentinel dosing group (2 subjects). Cohort 2 will commence after safety data from the first 2 doses from all Cohort 1 participants are reviewed.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cohort 1, Low Dose, Placebo | Placebo comparator | Other: PlaceboLow dose of placebo by intramuscular injection, 3 doses at 4-week intervals |
| Cohort 1, Low Dose, PRV-101 | Experimental | Biological: PRV-101Low dose of PRV-101 by intramuscular injection, 3 doses at 4-week intervals |
| Cohort 2, High Dose, Placebo | Placebo comparator | Other: PlaceboHigh dose of placebo by intramuscular injection, 3 doses at 4-week intervals |
| Cohort 2, High Dose, PRV-101 | Experimental | Biological: PRV-101High dose of PRV-101 by intramuscular injection, 3 doses at 4-week intervals |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy adults, males and females, ages 18 to 45 yrs, with BMI 19 to 30 kg/m2
- Women of childbearing potential must have negative pregnancy test and agree to use an acceptable method of highly effective contraceptive
- Men must either have a vasectomy or agree to use highly effective contraception
Key exclusion criteria (8 listed)
- Prior or current clinically significant medical illness or disorder
- Has celiac disease or type 1 diabetes or related autoantibodies
- Has active acute or chronic/latent infection, or history of recent serious infection
- Recent acute illness or recent major illness, hospitalization or surgery
- Recent history of alcohol or drug abuse
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PRV-101Coxsackie Virus B vaccine | Biological | Cohort 1, Low Dose, PRV-101, Cohort 2, High Dose, PRV-101 |
| PlaceboPlacebo | Other | Cohort 1, Low Dose, Placebo, Cohort 2, High Dose, Placebo |
Primary outcome
Incidence and severity of treatment-emergent adverse events (safety and tolerability)
Time frame: Throughout the 32 weeks of the study
Adverse events will be assessed by frequency and criteria for severity (mild, moderate or severe)
2 secondary outcomes
Development of neutralizing antibodies to coxsackie B virus (immunogenicity, efficacy)
Time frame: Days 1, 29, and 57 and Weeks 12 and 32
Titer of antibodies to coxsackie B virus (immunogenicity, efficacy)
Time frame: Days 1, 29 and 57 and weeks 12 and 32
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2022.
- Derived from this study: PubMed 38369573Hyoty H, Kaariainen S, Laiho JE, Comer GM, Tian W, Harkonen T, Lehtonen JP, Oikarinen S, Puustinen L, Snyder M, Leon F, Scheinin M, Knip M, Sanjuan M. Safety, tolerability and immunogenicity of PRV-101, a multivalent vaccine targeting coxsackie B viruses (CVBs) associated with type 1 diabetes: a double-blind randomised placebo-controlled Phase I trial. Diabetologia. 2024 May;67(5):811-821. doi: 10.1007/s00125-024-06092-w. Epub 2024 Feb 19.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chief Scientific Officer principal investigator
CRST Oy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PRV-101 in people with Viral; Infection, Coxsackie(Virus), run by Provention Bio, Inc. at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and severity of treatment-emergent adverse events (safety and tolerability) (time frame: Throughout the 32 weeks of the study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04690426, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2022.